The US FDA and other regulatory bodies requirements are continually evolving, so it is crucial to maintain a current understanding of the CQV development in order to maintain compliance.
We can support you across the full validation lifecycle of your manufacturing process including equipment, systems and facilities.
We have significant experience in the qualification of the following systems and equipment to ensure compliance with International Standards and Regulatory requirements including ICH and PIC/S:
Active Pharmaceutical Ingredient (API) manufacturer
Facility Qualification
Cleanroom and Associated HVAC System Qualification
Clean Utilities (Water & Steam)
Utility Gases and Compressed Air
Aseptic Filling Lines (Vial, Ampoule and Pre-Filled Syringe)
Visual Inspection (manual and automated processes)
Packaging equipment
Process validation
Cleaning validation
Thermal mapping
From User Requirements Specification (URS), risk and impact assessments through to qualification protocols (DQ, IQ, OQ, and PQ), Requirements Traceability Matrix (RTM) development, and Final Summary Reporting. Cloud 9 Consulting Ltd. can develop and execute the full validation lifecycle documentation for your projects.
Cloud 9 Consulting Ltd can provide support with your Pharmaceutical product registration in the Kingdom of Thailand, see the following short video presentation which describes the process step and timeline.
Our team of Quality and GMP Consultants are available to aid in your inspection preparation and remediation action plans.
Through a process of Gap Analysis, remediation identification, implementation management, and verification, we will aid in the preparation for your regulatory inspections.
Ensuring that your computerized systems are compliant with 21 CFR Part 11 Electronic Records, Electronic Signatures, and Eudralex Annex 11. We have expertise utilizing the Good Automated Manufacturing Practice (GAMP 5) guidelines and ASTM E2500 for the implementation of a risk-based approach to Computerized System Validation.
Cloud 9 Consulting Ltd professionals can support you in the implementation, project management, equipment selection, commissioning, qualification, and validation of your computerized systems, including:
Distributed Control Systems (DCS)
Supervisory Control and Data Acquisition (SCADA) systems
Programmable Logic Controller (PLC) based systems
Building Management Systems (BMS)
Environmental Monitoring Systems (EMS)
Laboratory Information Management Systems (LIMS)
Implementation and qualification of track & Trace/serialization of packaged pharmaceutical products
DATA INTEGRITY
Data integrity deficiencies will impact regulated organizations which could result in significant financial implications as well as lost reputations.
The FDA utilizes the ALCOA principle.
Attributable: Who performed the action and when? If a record is changed, who did it and why? Linked to the source data.
Legible: Data must be recorded permanently in a durable media and be readable.
Contemporaneous: The data should be recorded at the time the activity is performed and date and time stamps should follow in order.
Original: The information must be the original copy or a certified true copy.
Accurate: No entries or editing performed without documented amendments.
For new systems building ALCOA into the design specifications to ensure that the system will meet the Data Integrity requirements reduces the overall risk of non-compliance and failure. A collaborative approach with the system/equipment developer to implement suitable risk management, design reviews, change control, verification and acceptance testing are key to achieving robust computerized systems which meet the regulatory expectations for Data Integrity.
For legacy systems, a different approach is required:
GAP Analysis review of the system to identify areas of non-compliance.
Remediation of the system GAPs; can be implemented through control system software and/or hardware upgrades with robust test plans to verify the system functionality.
Where systems cannot be upgraded and in certain circumstances, interim manual controls can be implemented to provide a level of data integrity assurance; however, permanent automated solutions should be implemented.
Cloud 9 Consulting Ltd helps our customers to achieve Data Integrity compliance by offering the following services:
Legacy System Data Integrity Compliance Reviews.
Risk Management Implementation.
Interim Controls Implementation.
Data Governance Policy Implementation.
System Verification and Validation Documentation and Execution.
Ensuring that your quality critical equipment and systems are delivering the correct information require a robust maintenance and calibration approach, this should include equipment and instrument criticality assessment of each component to determine the level of calibration required.
Having a robust system of tracking and scheduling your calibration requirements is an important consideration to demonstrate that your company is in control of this quality critical aspect of your manufacturing processes.
Developed and delivered training covering PIC/S history and guidance, Data Integrity, CQV and GMP.
GCME Maptaphut, Rayong, Thailand
Developed and delivered training covering PIC/S history and guidance, Data Integrity, CQV and GMP.
Warehouse and Distribution Centre Project Pathum Thani, Bangkok, Thailand
Completed temperature mapping studies following the WHO guidance as required by the client, completed studies in 10 separate rooms, cold store warehouse and freezer across a temperature range of 25®C to -22®C.
